Spatula, Surgical, General & Plastic Surgery
FDA product code GAF · Class I (low risk) · 21 CFR 878.4800 · General, Plastic Surgery
5510(k) clearances
0PMA approvals
1recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K023688 | Lemaitre Vascular Disposable Vein StripperGAF · Traditional | LeMaitre Vascular, Inc. | 01/30/2003SE |
| K935357 | Snap Reciprocating SawGAF · Traditional | Surgiquip, Inc. | 01/28/1994SE |
| K890374 | Abdominal SpatulaGAF · Traditional | Kinetic Medical Products | 02/03/1989SE |
| K882793 | PMT Fukushima Microsurgical Instrument LineGAF · Traditional | Pmt Corp. | 07/18/1988SE |
| K822108 | Cement-PickGAF · Traditional | Bio-Blitz, Inc. | 08/11/1982SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0934-2025 Class II | ECONO STERILE medical procedure kits labeled as: ECONO STERILE CEMENT SPATULA #24 STRL…Reports of various packaging issues that may result in a breach of the sterile barrier. | Sklar Instruments | 12/03/2024Open, Classified |